Lead, Quality Control

Summary

Responsible to ensure compliance to cGxP standards for products within area of responsibility (during development, transfer and commercialization), including safety testing, monitoring and trending. Provide guidance, support and leadership for implementation of test methods, specifications and analytical standards.

About the Role

Key Responsibilities:

1. Ensure QC activities executed according to cGxP standards.
2. Collaboration in GxP audits/inspections.
3. Ensure methods and procedures are up to date.
4. Introduction of new technologies; drives implementation of new requirements.
5. Statistics for decision making. Maintenance and calibration of equipment.
6. Elaboration of the maintenance and calibration plan.
7. Improvements in Analytical Methods • Product and process validations.
8. Support validation and qualification with analysis. Process performance.
9. Drives the talent agenda: Leads people processes through recruitment, training, coaching and performance to meet all operation requirements and supports a robust career path deployment and succession plan for area of responsibility.
10. Invest time in personally developing and coaching talents.
11. Promote and improve the Safety and Quality cultures, by implementing the necessary systems and actions in line with the evolution of the site.
12. Ensure overall inspection readiness for area of responsibility.

Essential Requirement:

1. BS: 12+ years related experience with 5+ years in management.
2. Related experience should be in GMP-regulated industries in Quality Control.
3. Must have a working knowledge of health authority and regulatory requirements as well as industry quality management tools, standards, and quality systems.
4. Must have an understanding of pharmaceutical industry trends and practices.
5. Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.

Desired Requirement:

1. University degree with a scientific/technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent).